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The invention presented here involves an identifying device for the handling and identification of small implants (screws or other items) used in restoration surgery (orthopedic surgery, maxillo-facial surgery, osteosynthesis, etc.).
In an application that is of very much interest, the identifying device according to-the invention makes it possible to identify and follow the route of an implant having a reduced size (for example, on the order of 1 to 2 mm), from its manufacture to its implantation in a patient.
As of a recent date, a directive of the Commission of the European Community requires the tracking capability, i.e. the identification and the tracking of any material having a surgical use intended to be put into position in vivo, from its manufacture to its final usage, for example until it is implanted in a patients body. Each product leaving the factory of manufacture must thus be identified namely by a lot number that must be able to be read and noted at any moment. Thus, if an implant turns out to be defective for any reason, the identification number must make it possible or at least make it easier to determine the origin of the defect.
On the one hand, it is largely desirable that the surgeons or their practicing assistants in a surgical unit can, on the one hand, easily grasp the small implants such as screws used for the coaptation of fragments of bone or other items, and, on the other hand, read and report their number in the patients"" files. In addition, as soon as an implant is sterilized, the handling must be as indirect as possible (while staying easy) in order to not contaminate the implant.
The surgical material having a reduced size provided for the surgical unit and intended for implantation on a patient must thus be easily identifiable and easy to handle without its sterilization being compromised.
Modern surgery uses, in certain fields (orthopedics, maxillo-facial surgery, steosynthesis, operations on small bones, small fragments or extremities of the skeleton, ) very small-sized material (less than 2 mm) intended for implantation in the body of a patient.
Currently, the surgical material intended for xe2x80x9cin vivoxe2x80x9d implantation is delivered to hospitals either already sterilized and packaged in sterile boxes which are brought closed into a surgical unit for implantations or not sterilized. It is then divided into racks or trays by means of which it is then sterilized or autoclaved, before being brought into the surgical unit.
In the first case, which is a very expensive solution, it is easy to place in the boxes, before sterilization, labels containing the lot number, in a manner so that when the boxes are opened for the purpose of using the sterilized material, it is easy to collect the labels and place them in the patients"" files.
However, this packaging mode of implants requires the use of a sizeable volume of the boxes, which increases the cost of transport and complicates the storage and handling. Another disadvantage of this packaging mode is that one is sometimes led to open several boxes in order to obtain the necessary parts, while voiding the sterilization of the implants that are not used.
In the second case, the characterization of the implants permitting their identification and the traceability required by the European directive is very difficult to realize.
In fact, the identification number attributed to each implant or to each lot of implants comprises most often a sequence of several numbers and/or letters, and the engraving of this number directly on the implants, though it is possible and standard usage for relatively large implants, becomes almost unrealizable on implants having a reduced size, due to a lack of space. Supposing that a micro-engraving is possible in certain cases, the easy reading of this number, for example, by the surgeon or by one his assistants in the course of the operation would stay impossible, whether to the naked eye or using a magnifying glass. Another possibility would be to use the small space available on each implant in order to engrave signs of recognition occupying a very small surface in the form of a code, but there again, the reading of this code by the medical personnel is impossible without specialized equipment for decoding.
The purpose of the invention is, notably, to correct the disadvantages mentioned above.
According to the invention, this purpose is achieved by an identifying device consisting of a small implant and a matched identifying support, where this support consists of a body made, at least in part, of a material having a capacity for elastic deformation, this body consisting of a retentive housing, for example, a constrictive housing, having a form fitted to that of the small-sized implant matched to this support, and in which the implant is housed, at least in part, and the support consists additionally of a designation mechanism allowing its identification and, as a result, the recognition of the implant matched to this identifying support.
It is understood that according to the invention, each implant is clipped in an identifying support which has, for example, on one of its faces and in a manner that can be read easily, the inscription of the information necessary for the identification of the implant that it carries. The coupled assemblies of the identifying support/implant can be delivered unpackaged, then placed in boxes or containers for sterilization by steam at 138xc2x0 C. in an autoclave oven. The coupled assemblies of the identifying support/implant can be sterilized as many times as necessary without losing the identifying information of the implant. The device according the invention thus makes it very easy to identify and handle small surgical implants. The identifying device according to the invention also makes it possible to keep the material in place in the container, notably during the transport of the container.
A very significant advantage of the identifying device according to the invention is that it makes it possible to arrange, on the external surface of the support, a sufficiently large area so that a number or other identification mark can be engraved there so that it is easily readable, during the operation, by the surgeons or their assistants, i.e. at the moment of the implantation of the implants. It is understood that this possibility makes it much easier to obtain the traceability required by the regulatory documents.
The identifying device according to the invention also makes it possible in an advantageous manner to handle the implant using sterile instruments, without touching and thus without contaminating it, for example, when putting the implants, which were received unpackaged, into boxes.
According to another characteristic arrangement, the support of the identifying device according to the invention consists of a lateral slit opening into the retentive housing of the support, the edges of this slit being able to be spread apart or moved together, due to the elasticity of the material.
In this way, the implant or other small object can be put easily and almost instantly into the constrictive housing of the support or also taken out easily and rapidly from this housing.
According to another characteristic of the invention, the support of the identifying device consists of a lateral recess arranged in alignment with the constrictive housing and opening into it.
By this arrangement, the implant, such as a screw or other object, can be easily grasped and brought out from its matched support by means of an appropriate instrument such as previously sterilized forceps or tweezers, which contributes to the preservation of the sterile condition of the implant.